WVU Research Corporation Clinical Trials Physician in Morgantown, West Virginia
Description Positions are part time (29 hpw or less) with variable, intermittent work schedule.
Purpose To provide support for physician coverage and medical evaluation for research conducted at WVU CPRC as directed by the Medical Director. To function as a member of the team responsible for study conduct and be named as such on the FDA 1572.
Independently uses professional concepts and techniques, as well as organizational policies to solve a wide range of moderate to complex problems in imaginative and practical ways. Depth skills, knowledge, and interpretive abilities, as well as some creativity, are required to successfully perform duties. Work effort often addresses non-routine matters within established protocol, guidelines, and/or policies. Work effort has significant impact on client services and operations, producing moderate to major organizational, legal and financial results and/or liabilities. Position duties will require oversight of projects or programs, including coordination of work by others providing support of basic objectives.
Duties & Responsibilities Responsibilities are functional in nature, and performed under nominal supervision. Specific tasks include, but are not limited to: 1) Review the protocol for studies based on physician coverage and medical evaluation requirements 2) Maintain dispensing license and medical license 3) Personally conduct physical examinations, evaluate ECG’s, evaluate blood chemistry test results, drug screens, HIV test results, hepatitis test results, and any other required clinical interventions under the direction of the Medical Director 4) Provide counseling to subjects regarding test results according to applicable state and federal laws under the direction of the Principal Investigator 5) Maintain an environment of subject safety and maintain an ongoing assessment of the safety profile and risk mitigation of the study as directed by the Medical Director 6) Review and execute treatment of adverse experiences. Provide treatment, follow-up and reporting of adverse experiences as directed by the Medical Director 7) Familiarity with GCP and ICH guidelines as dictated by 21 CFR Part 50 (Protection of Human Subjects) and 21 CFR Part 56 (Institutional Review Board) 8) Provide “on call” coverage of studies scheduled at WVU CPRC as directed by the Medical Director.(on call means reporting to WVU CPRC and/or hospital to examine subjects and treat adverse experiences) 9) Comply with all regulatory, sponsor, and WVU CPRC guidelines for conducting clinical research and handling adverse experiences 10) Interact with appropriate FDA officials and sponsor representatives concerning study conduct, safety, drug accountability and other study related areas as requested 11) Participate (as assigned) in protocol reviews, study-related training, and appropriate clinical consultations with the sponsors. 12) Provides schedule of availability to the Medical Director for alignment of resources and planning 13) Provide medical coverage and evaluation as directed by the Medical Director.
Supervisory/Lead Role This position reports to the Medical Director. The incumbent normally receives no instructions on routine work, general instructions on new assignments. Typically determines methods and procedures on new assignments. General sharing of knowledge and team participation is expected in the role. Program, project or activity lead and work coordination responsibilities may occur or be assigned in this position. Guidance or supervision of others may be required.
Physical Demands This position requires standing and bending in the assessment and treatment of patients; requires manual dexterity used in drawing blood and processing the samples; prolonged periods of sitting and the ability to walk short distances. Work activities may require the use of elevators and/or stairs. Activities are predominantly non-manual though some manual work may be included.
Work Environment Work is performed in a normal clinic/hospital setting and a processing lab. Exposure to diseases, body fluids, chemical and biologic hazards is possible. Incumbent is responsible to know and comply with all safety procedures. The following items have been determined as possible job exposures of this position requiring WVU EHS medical monitoring: 1) Contact with Human Blood or Other Potentially Infectious Material (OPIM)- includes human body fluids other than feces, urine, tears and sweat. 2) Patient Contact- having contact with a patient, or with potentially contaminiated items including (but not limited to) blood and/or body fluids.
Requirements Requisite Qualifications Education and/or Experience 1) M.D. ; and 2) Experience in conducting clinical trials and/or the practice of medicine
Certifications, Licenses, Registrations 1) Medical license dispensing physician registration with valid credentials to practice medicine
Skills, Knowledge, Abilities 1) Maintains skills in, or knowledge of, professional principles, legal and/or reporting requirements affecting area of responsibility. 2) Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. 3) Skilled at writing correspondence and preparing reports. 4) Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals. 5) Ability to compute rate, ratio and percent and to draw and interpret bar graphs. 6) Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. 7) Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form. 8) Skilled at communicating effectively in oral and written methods. 9) Ability to interact sensitively, effectively and professionally with persons from diverse cultural, socioeconomic, educational, racial, ethnic and professional backgrounds and persons of all ages and lifestyle preferences. 10) Ability to establish effective working relationships with diverse individuals at various levels. 11) Ability to work independently, exercising judgment and professionalism. 12) Ability to rapidly learn institution, federal, and state statutes and regulations impacting the program and translate those to practical application. 13) Ability to handle a high level of detail. 14) Ability to coordinate multiple projects. 15) Ability to establish and maintain effective relationships and deal tactfully with departments, organizational units, related programs, and external agencies and individuals. 16) Knowledge of the mission, goals, and policies of the program. 17) Familiar with general computer applications including: Microsoft Office Programs and Internet search engines. 18) Ability to work as part of a team and with a degree of independence.
Behavioral Competencies 1) Technical skills – Strives to continuously build knowledge and skills; pursues training and development opportunities; assess strengths, weaknesses, and shares expertise with others. Recording of data will require precision. 2) Problem solving – Gathers and analyzes information, identifies problems, develops alternatives, uses reason even when dealing with emotional topics and works well in groups and resolves matters timely. 3) Internal & External Customer Service – Manages difficult or emotional matters with objectivity and openness; responds promptly to needs and requests for service and assistance; meets commitments and dates, notifies others if change occurs; provides, solicits and applies feedback; and builds goodwill through balanced contributions, positive approach, respect and support of others. 4) Communications – Demonstrates group presentation skills, participates in meetings, listens and gets clarification, is responsive and speaks clearly and persuasively in positive and negative situations. Writes and edits clearly and informatively, varies style to meet needs, presents numerical data effectively, and able to read and interpret written information. 5) Organizational Support – Aligns work and develops strategies to meet organizational goals; seeks to improve and promote quality; demonstrates accuracy and thoroughness; and upholds organizational expectations and values. 6) Self-Management – Responds to management direction; resourcefully adapts to changes in work environment and circumstances; responds well under pressure and manages competing demands; takes calculated risks, asks for and offers help when needed; exercise discretion and sound judgment; is tactful and responsible for own actions. Adheres to work schedule and complies with leave management responsibilities.
Requisition Number: 16-0054
Post Date: 4/21/2016
Title: Clinical Trials Physician
Position Type: Part Time
Work Hours: Intermittent